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The Next-Gen QMS Software Solutions

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To integrate, streamline, and simplify medical device and combination product design controls, risk management based on the industry best practices, and make product safety, effectiveness, time to market, cost of maintenance, compliance and quality a competitive advantage

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QMSpace™ Design Controls: All in One Solution for Design Controls


 - All in one solution for electronic Design History File (DHF) system in full compliance with applicable standards and regulations (e.g., CFR 820.30, ISO 13485, Part 11, and other FDA requirements).


- Out of box best practice-based configurable templates that facilitate the content creation, flow down, traceability, change impact for design input, design out, design verification, design validation, design transfer, control strategies, and risk management as applicable.

- Out of box best practice-based configurable templates for creating and maintaining DHF (Design History File) deliverables (technical documents, plans, reports, review memos etc.) and SOPs.

- Provides built in editor for rich text that are compatible with Microsoft Word. Provides built in editor for traceability tables that are compatible with Microsoft Excel.

- Provides solutions for managing the creation, maintenance, and reuse of platforms, variants / derivatives, and library information

- Provides configurable workflow to support team collaboration and change management at both individual work item level and DHF deliverable level.

- Provides project management tool for DHF deliverable tracking: interdependency, schedule, status, and action items

- Provides APIs for connectivity with other electronic systems

ISO 14971 Risk Management

QMSpace™ Risk Management: All in One Global Risk Management Solution


- Provide all in one solution for electronic Risk Management File (RMF) system in full compliance with applicable standards and regulations (e.g., ISO 14971, ISO 13485, Part 11, and other applicable FDA requirements)


- Provides all in one configurable solution for managing multiple risks (safety, cybersecurity, business, performance etc.) and multiple risk policy sets as needed for different business units or product families


- Provides out of box best-practice based configurable templates that facilitate the content creation, traceability, and change impact for Hazard Analysis, Task Analysis, Use Error Risk Analysis, Failure Mode and Effects Analysis (dFMEA and pFMEA), and Design Controls as applicable.


- Provides built in editor for rich text that are compatible with Microsoft Word. Provides built in editor for traceability tables that are compatible with Microsoft Excel


- Provides automatic risk value calculations and risk heat map generation based on the risk policy configurations.


- Provides built-in toolkit for Fault Tree Analysis (FTA) with reliability calculation 


- Provides solutions for managing the creation, maintenance, and reuse of platforms, variants / derivatives, and library information


- Provides APIs for connectivity with other requirement management tools 

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QMSpace™ Cybersecurity: All in One Global Cybersecurity Risk Management Solution


- Provides all in one solution for electronic Cybersecurity Risk Management File system in compliance with standards and regulations (e.g., AAMI TIR 57, AAMI SW96, Part 11, FDA guidance) 


- Provides out of box best-practice based configurable templates that facilitate the content creation, traceability, and change impact for Asset Profiling, Threat Modeling / Attack and Vulnerability Analysis, Exploitability Assessment, SBOM, and Security Risk Summary.


- Provides automatic connectivity with Safety Risk Management


- Provides configurable cybersecurity risk policy and built in CVSS, CWSS scoring system 


- Provides solutions for managing the creation, maintenance, and reuse of platforms, variants / derivatives, and library information

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QMSpace™ Assurance Cases:  All in One Assurance Case Development Solution

 

- Tabular, graphic, and narrative assurance case editors

​- Integrates assurance case method into design controls, risk management, and cybersecurity throughout the product life cycle.

​- Intuitively guiding for argument development that is needed for a robust assurance case of effectiveness, safety, cybersecurity, or compliance.

​​- Able to convert design controls, risk management, and cybersecurity information into an assurance case table or graphic.

​- Electronic submission of assurance cases to the FDA

 

Screenshots

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QMspace login page

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Design Input requirements

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System hazard anaylsis

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Failure modes and effect analysis

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risk assessment summary matrix

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design Control Trace Matrix

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design Control Module

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Risk Management module

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